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for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical DevicesMore than 700 questions with references to GMP/GDP regulations and EN ISO 13485 on the preparation and implementation of Good Distribution Practice (GDP) auditsYour perfect working tool: compact and practice-oriented!
2 PDF- and 1 Word file, 123 pages
2nd edition 2018
Delivery immediately after receipt of payment
Excerpt from the GMP Compliance Adviser More than 700 questions with references to GMP/GDP regulations and EN ISO 13485 on the preparation and implementation of GDP audits You need to prepare for an audit or an inspection to come, a self-inspection or your own GDP audit of suppliers and subcontractors? The GDP Audit Questionnaire facilitates an efficient preparation, helps you save a lot of valuable time and ensures that the requirements are fully met! This questionnaire is a practice-oriented tool for preparing and implementing self-inspections with an emphasis on GDP (Good Distribution Practice). Compliance with GDP requirements during the product life cycle of medicinal products for human use, their active substances, and medical devices can be monitored, checked and directly documented using a list of questions. The questionnaire is aimed at companies involved in the distribution chain of healthcare products, including:
It can also be used when auditing service providers in this environment. The individual questions contain direct references to the following regulations:
The questionnaire contains the following chapter from the GMP Compliance Adviser:
The GDP Questionnaire is your perfect working tool!
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This file is in PDF and Microsoft Word „.docx" format!
Filesize: 1,6 MB
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1st edition 2013 | ISBN: 978-3-943267-81-5
SOP "GMP-Questionnaire: Contract Manufacturing / Contract Analysis"Standard draft to adapt...
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